Schedule M: Good Manufacturing Practice

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Schedule M:

Schedule M describes Good Manufacturing Practices and Requirements of Premises. 
Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs.
Part 1: Describes Good Manufacturing Practices For Premises and Material

Part 1A: Describes the Specific requirement for manufacture of sterile products. Parenteral preparations (Small Volumn Injections and Large Volumn Parenterals) and Sterile Ophthalmic Preparations

Part 1B: Describes the Specific requirements for manufacture of oral solid forms (Capsule and Teblets)

Part 1C: Describes the Specific Requirements for Manufacture of Oral Liquids (Syrups, Elixirs, Emulsions and Suspensions)


Part 1D: Describes the Specific requirements for Manufacture of Topical Products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
Part 1E: Describes the Specific requirements for manufacture of Metered Dose Inhalers (MDI)

Part 1F: Describes the Specific requirements of premises, plant and material for manufacture of Active Pharmaceutical Ingredients (Bulk Drugs)

Part 2: Describes the Requirements of Plant and Equipment

Schedule M-1:

Schedule M-1 describes the Good Manufacturing Practice requirements of factory premises for manufacture of Homoeopathic preparations:

Schedule M-2:

Schedule M-2 describes the requirements of factory premises for manufacture of cosmetics

Schedule M-3:

Schedule M-3 describes the requirements of factory premises for manufacture of medical devices

(For detail analysis refer drug and cosmetic act and rules)

Author: Ajay Kamboj

Full Time Blogger, Part Time Entrepreneur and Partial Time Helper for New Start-UP's in Pharmaceutical, Ayurvedic and Nutraceutical Sector. Contact him at pharmafranchiseehelp@gmail.com

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